MedTrace Logo

Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication

NCT06514274 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2025-07-03

No results posted yet for this study

Summary

The purpose of this study was to evaluate the efficacy and safety of the triple therapy of berberine hydrochloride, vonorasan and amoxicillin for the primary eradication of Helicobacter pylori.It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Conditions

  • Helicobacter Pylori Infection
  • Chronic Gastritis

Interventions

DRUG

Berberine

Berberine 500 mg, twice daily for 14 days

DRUG

Vonoprazan

Vonoprazan 20 mg, twice daily for 14 days

DRUG

Amoxicillin

Amoxicillin 1000mg, twice daily for 14 days.

DRUG

Bismuth

Bismuth 220mg, twice daily for 14 days.

DRUG

Clarithromycin

Clarithromy 500mg, twice daily for 14 days.

DRUG

Esomeprazole

Esomeprazole 10mg, twice daily for 14 days.

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2025-04-30
Completion
2025-06-25

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06514274 on ClinicalTrials.gov